CSV Coordinator

Région
Wavre
Publication
mercredi 17 mai 2017
Date limite
samedi 17 juin 2017
Réf
747AEXPE-BE
Contact
Julie Begine
Fonction
Autre
Niveau d'expérience
0 à 2 ans d'expérience
Type de contrat
Fixe
Temps de travail
Temps plein
eXPErt services for eXPErt professionals.
That's XPE. For one of our clients we are looking for: CSV Coordinator Organisation description:

XPE Pharma & Science offers a unique combination of providing high qualified Scientific, Technical, Commercial and/or Medical expertise through staffing, consultancy, Project management or Project delivery services.

We have more than 250 XPErts helping out our clients in different phases of the development process of a drug/medical device or product.

As a full service organization XPE Pharma & Science offers those specialized HR & project services to Pharmaceutical, Biotech, Medical devices, Agri-food Industries and the Healthcare & CRO environment.

Job description:

Apply the R&D validation methodology for laboratory automated equipments qualification in the frame of local infrastructure projects respecting cGMP of EU, US and all other applicable regulations.

In the context of investments (new or upgrades) or alignment projects in Vaccine R&D, ensure proper execution of the R&D validation methodology and application of cGMP (Validation Master Plan, URS, RA, Design Qualification, Installation & Operational Qualification, Performance Qualification and Validation Reports) and specific regulations applicable to the “computer” domain.

Ensure the application of R&D SOPs.

Manage, schedule, coordinate and track each qualification or validation activities to ensure timely completion of the validation plan in coordination with Production, Technical, Quality Control, Quality Assurance and Regulatory departments.

Monitors that validation deviations are properly generated, managed and completed.

Coach the User, Technical Services, Validation and QA regarding the R&D validation methodology applied to automated systems.

Profile:

If you have an University level (engineering, automation, IT, biological laboratory equipment…) or equivalent by experience and you speak fluently French and English. You have at least three years experience in CSV applied to R&D or QC lab equipment.

Knowledge of main laboratory automation and IT principles and components (PLC, SCADA , HMI, network, spread sheets…), process control part of standard automated lab systems, such as : HPLC, Bioreactors / fermentors, ..., good practices in electronic records management, risk analysis methods applicable to computerized systems (such as FMEA), projects and qualification steps, including commissioning. You have already demonstrated success in implementing its discipline in minor or major projects.

  • Specific regulations and guidelines applicable to computerized systems (such as 21 CFR Part 11 (FDA), Annex 11 (EMEA)
  • Good skills and competencies level in validation activities : organization, understanding and implementation of validation practices in projects, time schedule, team working,
  • Good expertise in GMP Practices (V cycle, GAMP, Data Integrity)
  • Experience as suppliers' auditor would be an advantage
Offer:

What do we offer? Well for this position you will start as a Consultant at XPE Pharma & Science. As a consultant you will get an interesting salary package (contract of unlimited term) and extra-legal advantages!

If you are still interested, don't hesitate to apply…We have 2 working days to present your application with our client.

XPE is a part of the Adecco group, one of the top 5 companies for 'Best Place To Work'.



Licenses
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002
XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713